The rapid uptake and incorporation of computerized systems and electronic data management into clinical research needs to be backed up by sound validation processes to ensure data quality and integrity are not compromised, says the Drug Information Association (DIA), according to PharmaTimes.
The clinical research community “often underestimates” the impact “the use of electronic applications, computerized systems and the transmission of subject data may have on the quality and integrity of data and subject safety,” the DIA warned.
The Association was launching a new publication that applies and extends the standards formulated through the DIA’s Red Apple II GLP (Good Laboratory Practice) initiative, which addressed the design and testing of computerized systems in non-clinical research.
According to the DIA, Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts “provides a benchmark” for applying these technologies in the clinical research setting.
The new publication is designed to support “the many users struggling to implement validation processes into clinical research,” thereby stimulating innovation in the clinical research environment, the DIA explained. Proper validation and use of computerized systems will help to ensure the safety of research subjects and the credibility of clinical research data, it added.
The publication is the result of “exhaustive work” by a large group of participants from the global clinical research arena, noted Earl Hulihan, senior vice president, regulatory affairs at Medidata Solutions Worldwide.